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The Complete Guide to CDISC Standards Management

Our step-by-step guide will help you manage CDISC data standards with ease – so you can spend less time on admin, and instead focus on getting treatments to market more quickly! With our guide, you’ll learn: Get Your Free Complete Guide to CDISC Standards Management Submit the form below to learn how to best handle … Continued

Adopting CDISC Standards: Our Journey With CDISC

Highlights  ⬇️ Who are CDISC? ⬇️ Where our partnership began ⬇️ Encouraging the adoption of CDISC standards ⬇️ Visualizing CRFs for EDC Systems Who are CDISC? The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a grassroots initiative, in response to the need to better structure and improve the quality and consistency of … Continued

Using Define-XML for Faster, Better Quality and More Efficient Studies

Since its inception in 1997, the Clinical Data Interchange Standards Consortium (CDISC) has developed and supported globally adopted data standards to improve clinical trial efficiency. Clinical data standards are now recognized as playing a vital role in the entire end-to-end clinical trial process. Standardization allows for faster, better quality and less costly drug discovery.  One … Continued

How to Use CDISC’s ODM Standard for CRF Design

Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM.  This blog shines a spotlight on the lesser-known Operational Data Model … Continued

Why Should You Use LOINC Codes For SDTM?

In this blog, we take a detailed look at LOINC Codes and SDTM. We look at several LOINC code examples and examine why it’s beneficial to use the codes alongside CDISC and NCI controlled terminology. We also include details of where to find the official LOINC codes list.  What Are LOINC Codes Used For?  LOINC … Continued

The SDTM Mapping Process Simplified

SDTM mapping can be one of the most challenging programming problems in a clinical trial build. It involves mapping datasets from a non-CDISC structure, for example the structure used in your clinical data management system, to the CDISC SDTM structure, as required by CDISC standards.  These standards were put in place to make it easier … Continued

What Are SDTM Supplemental Qualifiers?

We touched on the SDTM supplemental qualifier in the SDTM mapping process simplified. In this blog, we’ll delve deeper into this subject with detailed examples. So, what are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard.  What To Do With … Continued

Define.xml Submission Checklist

Learn what mistakes to avoid when creating your define.xml How detailed should you be? When should you create a PDF file?… Whether you’re creating define files during a study or at the end, our checklist will help you avoid the pitfalls and tell you all you need to know to create a compliant Define.xml submission. … Continued

A guide to CDISC standards used in clinical research

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to helping improve medical research through data standardization. CDISC has worked closely with the FDA to introduce data standards, which make it easier for regulatory reviewers to understand and process clinical trial data. Standardized data has been a mandatory FDA requirement for all clinical studies submitted … Continued

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